510(k) K903843
- Device
- IMMUNODOT THYROID AUTOIMMUNITY PANEL
- Applicant
- GENERAL BIOMETRICS, INC.
- 510(k) number
- K903843
- Product code
- JNL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-10-02
- Date received
- 1990-08-21
- Regulation
- 866.5870
- Classification name
- Immunochemical, Thyroglobulin Autoantibody
- Medical specialty
- Immunology
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- BRYAN L KIEHL
- Address
- 15222 Ave. Of Science Suite A San Diego CA US 92128 92128
FDA Registration Numbers#
- 3002800697
- 3004192065
- 2032839
- 1318354
- 2020726
- 2432235
- 2029372
- 2245285
- 2122870
- 3022178699
- 3002806944
- 1219913
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JNL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250816 | ADVIA Centaur Anti-Thyroglobulin II (aTgII) | Siemens Healthcare Diagnostics, Inc. | 2025-12-04 |
| K240996 | Access Thyroglobulin Antibody II | Beckman Coulter, Inc. | 2024-07-03 |
| K112933 | ACCESS THYROGLOBULIN ANITBODY | Beckman Coulter, Inc. | 2011-12-27 |
| K072661 | IMMUNOCAP THYRLOBULIN IMMUNOCAP | Phadia US, Inc. | 2007-11-20 |
| K062516 | ACCESS THYROGLOBULIN ANTIBODY II ASSAY, MODELS A32898 (REAGENT) AND A36920 (CALIBRATORS) | Beckman Coulter, Inc. | 2006-10-05 |
| K971834 | ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISA | Monobind | 1997-07-03 |
| K962341 | HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROGLOBULIN (TG) | Hycor Biomedical, Inc. | 1996-11-25 |
| K962451 | HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROID MICROSOMAL (TPO) | Hycor Biomedical, Inc. | 1996-11-25 |
| K954256 | ANTI-TPO | Biomerica, Inc. | 1995-11-27 |
| K951362 | THYROGLOBULIN EIA TEST KIT | Immunoprobe, Inc. | 1995-11-20 |
| K951364 | MICROSOMAL EIA TEST KIT | Immunoprobe, Inc. | 1995-11-20 |
| K951320 | AURAFLEX TG-AB AND TPO-AB | Organon Teknika Corp. | 1995-08-25 |
| K952607 | AURAFLEX TPO-AB | Organon Teknika Corp. | 1995-08-25 |
| K943580 | AUTOSTAT II ANTI-TPO | Cogent Diagnotics , Ltd. | 1995-04-17 |
| K941358 | THYROGLOBULIN EIA TEST KIT | Immunoprobe, Inc. | 1994-05-11 |
Legacy Summary#
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FDA Review#
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